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Acetaminophen Versus IV Hydromorphone for Pain in the Elderly in the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521102
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description
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Brief Summary:
Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Acetaminophen 1000mg IV Drug: Hydromorphone 0.5 mg IV Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Acetaminophen 1000mg IV
NRS pain scores will be obtained at 5, 15, 30, 45, 60, 75, 90, 105 and 120 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.
 Drug: Acetaminophen 1000mg IV
1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push
Active Comparator: Hydromorphone 0.5mg IV
NRS score will be checked at 5 minutes and every 15 minutes for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.
 Drug: Hydromorphone 0.5 mg IV
100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push


Outcome Measures
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Primary Outcome Measures :
  1. Verbal pain scale (0-10) [ Time Frame: 60 minutes ]
    Improvement in 0-10 verbal pain scale between baseline and at 60 minutes


Secondary Outcome Measures :
  1. Need for rescue medication [ Time Frame: 120 minutes ]
    Requirement of additional analgesic medication


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age equal to 65 or greater
  2. Pain onset within 7 days with severe pain
  3. Has capacity to provide informed consent
  4. Understanding English or Spanish

Exclusion Criteria:

  1. Use of tramadol or opioids within 7 days
  2. Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
  3. Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
  4. Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
  5. Alcohol intoxication
  6. Systolic blood pressure: < 100 mmHg
  7. Heart rate: < 60 beats per minute
  8. Oxygen saturation: < 95% on room air
  9. Use of monoamine oxidase (MAO) inhibitors in the past 30 days
  10. Use of transdermal pain patch or oral opioid > 10 days in the prior month
  11. Prior enrollment in the same study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521102


Contacts
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Contact: Alexander V Latev, MD 4254437245 alatev@montefiore.org
Contact: Benjamin Friedman, MD befriedm@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Benjamin W Friedman    718-920-6626    befriedm@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Benjamin Friedman, MD Montefiore Medical Center
More Information
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Responsible Party: Benjamin W. Friedman, MD, Professor, Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03521102    
Other Study ID Numbers: 2018-8876
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Acetaminophen
Hydromorphone
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants